Clinical Trial Administrator

The Clinical Trial Administrator (CTA) fulfils a specialized research role within the Clinical Research department. The CTA supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of a study. This role is responsible for preparing and maintaining Clinical Trial documentation and supervising administrative activities. In performing these duties, the CTA works closely with Clinical Research Associates to support and provide guidance on the administration of all related aspects of a clinical study. The Clinical Trial Administrator is based in a Kerecis office and reports to the Director of Clinical Affairs. This is a full-time role. Major Areas of Accountability Assist in the preparation and maintenance of clinical trial documentationSubmit clinical trials to institutional review boards/ethics committeesCooperate with Clinical Trials MonitorsParticipate in Clinical Trials team meetingsConduct correspondence and make telephone contact with study sitesReporting ongoing progress to project manager(s)Maintain and report identified metricsPrepare other study materials, including but not limited to enrollment logs, drug/device accountability logsPrepare applicable submission forms and submit updated documentsEstablish and organize study files, including but not limited to study-specific source documentation, regulatory binders and other materialsAssist principal investigator/site in communicationWeekly phone calls to each study center to aid shipment of product and other study materialsDocument status of each center’s recruitment, number of screened patients, enrolled patients, and their current week status, dropouts, and patients that have completed the study; all study documents should be uploaded and organized appropriately in SharePointPrepare monthly status updates on study progress for meetings and the Clinical NewsletterPrepare agendas and take notes for all Clinical Development team meetings (Project Check-in, Trial Council, Monthly Presentations, etc.)Serve as Administrative Secretary of Trial CouncilSubmit and process all vendor/site/contractor invoices in a timely manner upon receipt and follow up with Finance and Accounting until approved. Ensure Net 30 payment terms are adhered toSubmit required POs for study center recruitment and materials for the trialCompile study binders for sites and ship them to sites as neededTrack documentation required for each center and file them appropriatelyLabel study material appropriately with designated stickers and Serial Numbers, as needed, to prepare for shipment to sitesRequest Kerecis and control material for study and facilitate shipment of study materials to sitesAnticipated travel Kerecis employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.Other job duties as assigned Basic Qualifications One year of experience as a clinical research coordinatorExperience managing device or pharmacology trials or evidence of experience/education in clinical studiesVery good knowledge of the English language (enabling free verbal and written communication and understanding of content related to the field of clinical research)Conscientiousness, precision and consistency in carrying out assigned tasksHigh interpersonal skillsAbility to work with a large teamHigh level of motivation and commitmentHigh organizational skills (setting priorities and managing multiple tasks)Experience with processing payments / invoices through accounting and finance departmentsOpenness to new challenges and willingness to continuously improve skillsKnowledge of ICH GCP principles an assetGood knowledge of Microsoft Office suiteEffective time managementCommunicativeness, ease in establishing contacts Preferred Qualifications Bachelor’s degree in science-related field from an accredited college or university preferred Base Salary Range: $65,000 - $85,000 This job description is intended to set forth the core functions required for this position and describe the general nature of the work to be performed. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Job duties, responsibilities and activities may change or be supplemented at any time as necessary. Kerecis is an Equal Opportunity Employer. 61975